Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Launched by N.N. PRIOROV NATIONAL MEDICAL RESEARCH CENTER OF TRAUMATOLOGY AND ORTHOPEDICS · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how different types of pain affect patients with degenerative lumbar stenosis—a condition that narrows the spinal canal and can cause pain in the back and legs. The study aims to understand the role of both preoperative and postoperative neuropathic pain (pain caused by nerve issues) in patients who are scheduled for surgery to relieve pressure on the spinal cord. By doing this, the researchers hope to improve treatment and recovery for individuals dealing with this condition.

To be eligible for the trial, participants should be between 18 and 85 years old, experience leg pain that may come with back pain, and have symptoms that have lasted for at least three months. They must also plan to undergo surgery for their condition. Participants will need to agree to follow the study's guidelines and attend follow-up appointments. Throughout the trial, participants can expect regular assessments of their pain and recovery, which will help researchers learn how to better manage pain in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-85 years;
• • 2. Radicular leg pain with or without neurogenic claudication with or without back pain;
• • 3. Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
• • 4. Symptoms persisting for at least 3 months prior to surgery;
• • 5. Given written Informed Consent;
• • 6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
• Exclusion Criteria:
• • 1. Prior lumbar fusion at any level;
• • 2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
• • 3. Back or non-radicular pain of unknown etiology;
• • 4. History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
• • 5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
• • 6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).